New incident report
Incident Report Number: 2019-3158
Registrant Reference Number: USA-BAYERBAH-2019-US0025181 (Report 566943)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: CALIFORNIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Cat (Flumethrin-Imidacloprid) Collar
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Turkish X Angora crossbred
1
Female
7
4.536
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 17-May-2019 the cat exhibited lethargy, one episode of emesis that resolved approximately 5 minutes post onset, and vocalization. On 24-May-2019 the cat exhibited weight loss, hypersalivation, convulsions, and the cat died. No necropsy was performed. The cat was not evaluated by a veterinarian and no treatments were performed.
Death
O - Unclassifiable/unassessable Reported vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Time to onset is long. Reported lethargy and vocalisation are also unspecific and may have numerous other causes. Signs may occur initially after collar administration. Time to onset is consistent for these signs. Lethargy in this case may be associated with vomiting. The product is not anticipated to cause serious neurological disorders such as convulsions after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Hypersalivation may be associated with convulsions. Weight loss and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Time to onset is long. Hence, other causes must be considered. Overall, considering all aspects, a product relation for the case remains unassessable.